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Here you can find expert-curated courses relating to anything within the Medical Device world.
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Here you can find expert-curated courses relating to anything within the Medical Device world.
Clinical Evaluations continue to be one of the most discussed and complicated areas of regulatory documents. This course dives into CERs under MDR using ISO 18969 and relevant MDCGs whilst still leaning on the guidance of MEDDEV 2.7/1 rev4.
Sterilisation of medical devices is a crucial part of a product's validation. This course covers the basic concepts of microbiology as well as the general notions of each available type of sterilisation.
With the implementation of the AI Act, there's some confusion among manufacturers that have to comply with both the AI Act and MDR. This training aims to bring alignment between the two.